BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11280280 · Received February 4, 2021

    Report

    Report Number
    3006630150-2021-00278
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7072439/7072769.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSTOP INFECTION AT THE MIDLINE INCISION SITE. SYMPTOMS OF MILD SORENESS AND IRRITATION WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND IT WAS UNKNOWN IF PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PRESCRIBED ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176718 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366492 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention